Qualification & Validation
Qualification & Validation
Quality Assurance
Quality Assurance
Regulatory Affairs
Regulatory Affairs
Clinical
Clinical
Lab Services
Lab Services
Vigilance
Vigilance
Software Solutions & Services
Software Solutions & Services
Tox green
Toxicology
Pharma (2)
Pharma & Biotech
Medical Devices (2)
Medical devices
IVD (2)
In vitro diagnostics
Search QbD Group
  • There are no suggestions because the search field is empty.
Annual Product Review (APR) & Product Quality Review (PQR) QbD group

Annual Product Review (APR) & Product Quality Review (PQR)

Streamline your APR and PQR processes with expert support

Do you need to complete one or multiple Annual Product Reviews (APR) or Product Quality Reviews (PQR)? These mandatory tasks often coincide with other pressing activities, making it challenging to manage effectively. QbD Group offers full support for PQR writing, data analysis, and review, helping you stay compliant and efficient.

Read more

What is APR/PQR Support?

An APR or PQR evaluates product quality and performance to ensure safety, compliance, and market readiness. QbD Group provides end-to-end support for the entire process, from crunching the data to compiling comprehensive reports. Key aspects of APR/PQR support:

  • Comprehensive data management: Gathering, processing, and analyzing data from multiple systems.

  • Regulatory compliance: Ensuring all reviews meet GMP and regulatory standards.

  • Detailed reporting: Generating complete reports with proposed action plans.

  • Yearly insights: Providing trend analysis across PQRs to identify opportunities for improvement.

Discover why APR/PQRs are essential

Annual Product Review (APR) & Product Quality Review (PQR) QbD group (1)

Why are APR/PQRs important?

  • Patient Safety: APR and PQR processes detect potential risks, ensuring products meet safety standards and safeguarding patient health.
  • Supply Chain Stability: Timely reviews prevent production setbacks and stockouts, ensuring consistent product flow.
  • Sales and Market Reputation: Up-to-date reviews ensure regulatory approval and timely market readiness, protecting your company’s reputation.

 

Discover how we can support you

How can we help?

QbD Group offers tailored APR/PQR services to meet your organization’s unique needs:

Deadline management

Deadline management

Ensuring timely completion of all reviews.

PQR writing

PQR writing

Compiling comprehensive reports ready for approval.

Data analysis and statistics

Data analysis and statistics

Crunching numbers and identifying trends.

Review for compliance

Review for compliance

Ensuring consistency and regulatory alignment.

Annual Product Review (APR) & Product Quality Review (PQR) QbD group (2)

Why QbD Group?

Partnering with QbD Group for APR/PQR support provides:

  • Expert knowledge: Extensive experience ensures precise and thorough data evaluation.

  • Ready-to-approve reports: Receive reports with actionable insights, ready for your approval.

  • Workload management: Reduce the burden on your QA team during peak periods.

  • Scalable solutions: Handle multiple products or reviews efficiently and consistently.

Contact us
doc-mask

Our process

1. Assessment

We analyze your current processes and identify gaps.

2. Workshops

We work with your stakeholders to understand requirements and design solutions.

3. Documentation development

We create tailored procedures, policies, and manuals that meet regulatory standards.

4. Training and implementation

We equip your team with the skills to adopt, implement, and maintain the QMS.

contact-mail

Get in touch

Ready to simplify your Annual Product Review or Product Quality Review process?

QbD Group provides end-to-end APR/PQR support, ensuring compliance, efficiency, and actionable insights. Contact us today to learn more.

QualityAssurance_Get in touch

What information do you need from us to start the APR?

We’ll need access to relevant product data, batch records, quality metrics, and previous review documents. We’ll guide you through the data collection process to ensure everything is in place.

Can you handle complex products with multiple components?

Yes, we have experience with complex products and multi-component systems. Our team ensures every component is properly assessed.

How do you manage confidential product information?

We follow strict protocols to handle your product data securely. All information is shared only within our trusted team.

What if we have multiple products that need APRs?

We can handle APRs for multiple products simultaneously, ensuring consistency and streamlining the process.

How do you address issues or deviations found during the APR?

We identify deviations during the review and provide clear recommendations for corrective actions, complete with a detailed action plan.

Can you integrate our existing quality management system into the APR process?

Yes, we align with your existing QMS to ensure the review process integrates seamlessly with your internal procedures.

How will we know the APR is completed on time?

We provide a clear timeline and regular updates, so you always know when to expect the completed review.